CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
Philips VL13-5 Transducer recalled by Philips Ultrasound
Philips Ultrasound is recalling Philips VL13-5 Transducer, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2063-2025
- FDA event ID
- 96994
- Recalling firm
- Philips Ultrasound, Reedsville, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 2 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 May 2025 | Recall initiated by company | |
| 2 Jul 2025 | Classified by FDA | +35 days |
| 9 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ultrasound transducer devices were refurbished beyond their useful life.
Product as listed by the FDA
Philips VL13-5 Transducer.
Where it was distributed
Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.
Questions about this recall
Why was it recalled?
Ultrasound transducer devices were refurbished beyond their useful life.
Which lots are affected?
Model No. 989605409592, 989605372211, 989605372213; UDI: (01)00884838061606(21)B1C23Z, (01)00884838061606(21)B252D4, (01)00884838061606(21)B12ZWV, (01)00884838061606(21)B12QQC, (01)00884838061606(21)B23P58, (01)00884838061606(21)B0X3RL, (01)00884838061606(21)B12RN0, (01)00884838061606(21)B13BCL, (01)00884838061606(21)B1F233, (01)00884838061606(21)B2DWNC, (01)00884838061606(21)B12RN4, (01)00884838061606(21)B12ZTJ, (01)00884838061606(21)B1XR83, (01)00884838061606(21)B13DFT, (01)00884838061606(21)B12QVB, (01)00884838061606(21)B18LZX, (01)00884838067493(21)03FNNG, (01)00884838067493(21)038VY0, (01)00884838067493(21)03926P, (01)00884838067493(21)0367GM, (01)00884838067493(21)036BRP; Serial No. B1C23Z, B252D4, B12ZWV, B12QQC, B23P58, B0X3RL, B12RN0, B13BCL, B1F233, B2DWNC, B12RN4, B12ZTJ, B1XR83, B13DFT, B12QVB, B18LZX, 03FNNG, 038VY0, 03926P, 0367GM, 0399WM, 036BRP, 039250.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
19 other products · FDA event 96994This product is part of a recall event; the main page for the event is Philips eL18-4 EMT Transducer recalled by Philips Ultrasound.
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